Anchoring system for a medical article

ABSTRACT

An anchoring system secures a catheter to the body of a patient and arrests axial movement of the catheter without meaningfully impairing fluid flow through the catheter. The anchoring system includes an anchor pad that adheres to the patient&#39;s skin and supports a retainer. The retainer includes interacting structure with a cooperating keeper and latch that releasably moves the retainer between an open and a closed position. When in the open position, the retainer can receive a portion of the catheter and be subsequently moved to the closed position. The retainer further includes one or more retention mechanisms that inhibit axial movement of the catheter relative to the retainer when the catheter is secured therein. In one mode, the retainer includes interacting structure with a keeper and latch. The keeper selectively cooperates with the latch to secure the retainer in a closed position where the cover is generally over to the base. In another mode, the anchoring system includes a mount that allows the retainer to rotate 360° relative to the anchor pad.

RELATED CASES

This application is a continuation of U.S. application Ser. No.11/045,673, filed Jan. 28, 2005, which is a continuation of Ser. No.10/107,546, filed Mar. 26, 2002, which issued as U.S. Pat. No.6,951,550, which is a continuation of U.S. application Ser. No.09/379,827, filed Aug. 24, 1999, which issued as U.S. Pat. No.6,361,523, which is a continuation-in-part of U.S. application Ser. No.09/049,825, filed Mar. 27, 1998, which issued as U.S. Pat. No.6,283,945, which claims the benefit of provisional Application No.60/062,323, filed Oct. 17, 1997, each of which is hereby incorporatedherein by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field on the Invention

The present invention relates to an anchoring system for securing amedical article to a patient to inhibit movement or migration of themedical article relative to the patient.

2. Description of Related Art

Hospitalized patients often have limited mobility due either to theircondition or to doctor's orders. Such patients must lie in bed and notmove about their hospital room, even to urinate. As such, a Foleycatheter is often used with the bed-confined patient to drain urine fromthe patient's bladder. Use of a Foley catheter thus eliminates toilettrips as well as reduces bedpan use.

A Foley catheter typically includes two coaxial lumens: a drainage lumenand an inflation lumen. The inflation lumen communicates with aninflation balloon located at the tip of the catheter (i.e., the catheterproximal end). The proximal end of the drainage lumen includes one ormore influent openings to receive urine from the bladder. The lumensusually diverge in a Y-type pattern at the distal end of the catheter toform an effluent port and an inflation port.

In use, a healthcare provider inserts the Foley catheter through theurinary tract of the patient to locate the tip of the catheter withinthe patient's bladder. Although the catheter usually includes asiliconized outer coating as provided by the manufacturer, healthcareproviders often apply further lubricant, such as, for example,water-based jelly. The provider then inflates the balloon by attachingthe inflation port to a source of pressurized working fluid (e.g.,saline solution). Once inflated, a valve, which is located at theinflation port, inhibits the flow of fluid from the inflation lumen andthe balloon to keep the balloon inflated. The inflated balloon preventsthe catheter from unintentionally dislodging from the bladder. Thehealthcare provider then connects the distal end of the drainage lumen(i.e., its effluent port) to a drainage tube leading to a collectioncontainer.

The healthcare provider usually secures the distal end of the Foleycatheter to the patient using tape. The healthcare provider commonlyplaces long pieces of tape across the distal end of the catheter in acrisscross pattern to secure the catheter distal end to the inner thighof the patient. This securement inhibits disconnection between thecatheter and the drainage tube, as well as prevents the catheter ordrainage tube from snagging on the bed rail or other objects.

Taped connections, however, often collect contaminates and dirt. Normalprotocol therefore requires periodic tape changes in order to inhibitbacteria and germ growth at the securement site. Frequent tape changesthough lead to another problem: excoriation of the patient's skin. Inaddition, valuable time is spent applying and reapplying the tape tosecure the catheter. And healthcare providers often remove their gloveswhen taping because most find the taping procedure difficult andcumbersome when wearing gloves. Not only does this further lengthen theprocedure, but it also subjects the healthcare provider to possibleinfection.

A number of catheter securement devices have been developed to obviatethe need for frequent application of tape. U.S. Pat. Nos. 5,304,146 and5,342,317 disclose several examples of such devices. Although thesedevices hold the catheter to the patient, they fail to arrestlongitudinal movement of the catheter. These devices rely upon frictionbetween the catheter and a band wrapped over the catheter to preventaxial movement. Such contact between the catheter and the securementdevice, however, often fails to arrest longitudinal (i.e., axial)movement of the catheter, especially when used with a lubricatedcatheter (e.g., a Foley catheter).

Other securement devices have attempted to improve the securement ofFoley catheters. One such securement device is disclosed in U.S. Pat.No. 4,397,647. The approach taught by this patent, however, at leastpartially occludes the catheter and prevents the free flow of urinethrough the catheter. Improper drainage of the bladder consequently canoccur, leading to patient discomfort and possible medical complications(e.g., infection).

A need therefore exists for a simply-structured anchoring system thatsecures a catheter to a patient, without occluding or otherwiserestricting fluid flow through the catheter.

SUMMARY OF THE INVENTION

One aspect of the present invention thus involves an anchoring systemfor securing a medical article to the body of a patient. The systemcomprises an anchor pad having an upper surface and a lower surface. Thelower surface has an adhesive layer which adheres to the body of apatient. A retainer is mounted onto the upper surface of the anchor padand receives a portion of the medical article. The retainer is formed bya base and a cover. The base has a first side and a second, oppositeside. The base also includes a groove having a curvilinearcross-sectional shape. The cover is formed in a similar manner as thebase. The first side of the cover attaches to the first side of the baseand the second side of the cover is moveable between a closed position,in which the second side of the cover lies generally above the secondside of the base, and an open position, in which the second side of thecover is spaced apart from the second side of the base so as to exposethe groove in the base. When the cover is closed, the grooves in thebase and cover define a channel having a curvilinear cross-sectionalshape. The cross-sectional area of the channel varies over the length ofthe channel. Also, a latching mechanism, which is operable between thebase and the cover, releasably secures the second side of the cover tothe second side of the base.

Another aspect of the present invention involves an anchoring systemincluding an anchor pad with an upper surface and a lower surface. Atleast a portion of the lower surface is formed with an adhesive layerfor attachment to the patient's skin. A retainer is permanently affixedto the upper surface of the anchor pad and comprises a base and a cover.The base has a first groove to receive at least a portion of anelongated medical article. The cover is pivotally coupled to the baseand moveable between an open position and a closed position. In the openposition, the groove is exposed, and in the closed position, the grooveis covered. The cover also includes a second groove that cooperates withthe first groove when the cover is in the closed position to define achannel. The channel is configured to support the portion of the medicalarticle received by the retainer on at least diametrically opposed sidesthereof along the entire length of the received portion of the medicalarticle. At least one retention member projects into the channel and isarranged to engage a portion of the medical article to inhibitlongitudinal movement of the medical article through the channel.Interengaging structure also cooperates between the base and cover toreleasably secure the cover to the base.

In accordance with an additional aspect of the present invention, theanchoring system comprises an anchor pad with upper and lower surfaces.At least a portion of the lower surface is formed by an adhesive layer.A retainer is affixed to the upper surface of the anchor pad andcomprises a base and a cover. The base has a first groove to receive atleast a portion of the elongated medical article. The cover is pivotallycoupled to the base and is moveable between an open position and aclosed position. The cover also includes a second groove that cooperateswith the first groove when the cover is in the closed position to definea channel. The channel is configured to accept a portion of the medicalarticle received by the base. The base and cover include interengagingstructure which releasably secures together the base and the cover inthe closed position. At least one retention mechanism is positionedwithin the channel and includes at least first and second members thatare arranged to cooperate with one another when the cover is closed tohold a structural portion of the medical article between the first andsecond members without substantially occluding the inner lumen of themedical article.

Another aspect of the present invention involves an anchoring system forsecuring an elongated medical article to the skin of a patient. Theanchoring system includes a retainer comprising a base and a cover. Thecover is pivotally coupled to the base and is movable between an openposition and a closed position. A latching mechanism operates betweenthe base and the cover to selectively secure the cover to the base whenthe cover is in the closed position. The latching mechanism has anoperator attached to either the cover or the base, and is depressiblefrom a locked position to an unlocked position. The latching mechanismsecures the cover to the base with the operator in the locked position.The latching mechanism also permits movement of the cover relative tothe base with the operator in the unlocked position.

In one mode, the latching mechanism includes a set of interengagingmembers that engage together with the cover in the closed position. Theoperator is connected to at least one of the interengaging members todisengage the interengaging members when the operator is depressed intothe unlocked position. In a preferred form, the interengaging memberscomprise a keeper and a latch that receives the keeper in the lockedposition. The operator is connected to the latch. Both the keeper andthe latch include tangs that interlock when the operator is in thelocked position and the cover is in the closed position. The keeperincludes a deflectable bar that is attached to and extends from eitherthe base or the cover and supports one of the interlocking tangs. Thelatch includes an actuating bar. The actuating bar is attached to andextends from either the base of the cover and supports the otherinterlocking tang. The operator is connected to the actuating bar suchthat when the operator is depressed, the actuator bar bends to therebydisengage the respective tang from the tang of the keeper. In onevariation, the operator includes a channel in which the tang of thelatch is disposed. The channel is sized to receive at least a portion ofthe keeper. This latching mechanism presents a simply structuredmechanism that is easily actuated to lock and unlock the cover from thebase.

Another aspect of the present invention involves an anchoring systemincluding an anchor pad having an upper surface and a lower surface. Atleast a portion of the lower surface is formed with an adhesive. Aretainer is rotatably attached to the upper surface of the anchor pad.The retainer includes a base and a cover, with the cover being pivotallycoupled to the base. The cover is movable between an open position and aclosed position. The cover and the base cooperate to define a channelwhen the cover lies in the closed position. The channel is configured toreceive at least a portion of the elongated medical article. At leastone retention member projects into the channel is arranged so as to becapable of engaging a portion of the medical article and inhibitingaxial movement of the medical article through the channel. A latchingmechanism operates between the base and the cover of the retainerselectively secure the cover to the base when the cover is in the closedposition. The pivotal movement of the retainer relative to the anchorpad allows the orientation of the medical article retained by the anchorsystem to change so as to ease connection and disconnection of themedical article from the anchoring system, as well as for aligning theretained medical article with associated medical components.

Further aspects, features and advantages of the present invention willbecome apparent from the detailed description of the preferredembodiments that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

The above mentioned and other features of the invention will now bedescribed with reference to the drawings of preferred embodiments of thepresent anchoring system. The illustrated embodiments of the anchoringsystem are intended to illustrate, but not to limit the invention. Thedrawings contain the following figures:

FIG. 1 is a perspective view of an anchoring system in accordance with apreferred embodiment of the present invention and illustrates theanchoring system from a proximal end;

FIG. 2 is a perspective view of the anchoring system of FIG. 1 from adistal end;

FIG. 3 is a bottom view of the anchoring system of FIG. 1;

FIG. 4 is an enlarged perspective view of a retainer of the anchoringsystem of FIG. 2 with a cover of the retainer in an open position;

FIG. 5 a is a perspective view of the retainer illustrated in FIG. 2with the cover in a closed position;

FIG. 5 b is an elevational view of a distal end of the retainer of FIG.5 a;

FIG. 6 is a top plan view of the retainer of FIG. 4 with the cover in afully open position;

FIG. 6 a is a top plan view of a retainer configured in accordance witha variation of the retainer shown in FIG. 6 and illustrates a channelgroove on the base that includes a convex wall section;

FIG. 7 is a cross-sectional view of the retainer of FIG. 5 a, takenalong the line 7-7;

FIG. 8 is a cross-sectional view of a latch receptacle of the retainerillustrated in FIG. 6, taken along the line 8-8;

FIG. 9 is a cross-sectional view of the retainer of FIG. 5 a, takenalong the line 9-9;

FIG. 10 is a partial side elevational view of the retainer of FIG. 6 asviewed in the direction of line 10-10, and illustrates the cover and anassociated latch mechanism of the retainer;

FIG. 11 is a perspective view of the anchoring system of FIG. 1, andillustrates the cover in an open position and a catheter aligned abovethe anchoring system for insertion therein;

FIG. 12 is a perspective view of the anchoring system of FIG. 1, andillustrates the cover in a partially closed position with a channelformed by the cover and base of the anchoring system receiving thecatheter;

FIG. 13 is a perspective view of the anchoring system of FIG. 1, andillustrates the cover in a closed position with the catheter securedwithin the channel of the anchoring system;

FIG. 14 is a perspective view of a retainer in accordance with anotheradditional embodiment of the present invention;

FIG. 15 is a perspective view of the retainer of FIG. 14, illustratingthe retainer in the open position;

FIG. 16 is a top plan view of the retainer of FIG. 14, illustrating theretainer in the fully open position;

FIG. 17 is a cross-sectional view of the retainer of FIG. 14 taken alongline 17-17, illustrating a latch mechanism;

FIG. 18 is a cross-sectional view of the retainer of FIG. 17, with thecover moved towards a closed position;

FIG. 19 is a cross-sectional view of the retainer of FIG. 17, with thecover in a partially closed position and the components of the latchmechanism beginning engagement;

FIG. 20 is a cross-sectional view of the retainer of FIG. 17,illustrating the cover in a fully closed position and the components ofthe latching mechanism engaged;

FIG. 21 is a is a perspective view of another preferred embodiment ofthe anchoring system of the present invention and illustrates theanchoring system from a distal end with a retainer rotatably mounted ona mount base;

FIG. 22 is a cross-sectional view of the anchoring system of FIG. 21taken along line 22-22;

FIG. 23 is an enlarged detail view of a cross-sectional view of arotatable mount of FIG. 22 circumscribed by line 23-23; and

FIG. 24 is an enlarged, exploded detail view of a rotatable mount and athrough-hole in the retainer of FIG. 23.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

The present embodiment of the medical article anchoring system isdisclosed in the context of an exemplary Foley type catheter. Theprinciples of the present invention, however, are not limited to Foleycatheters. Instead, it will be understood by one of skill in this art,in light of the present disclosure, that the anchoring system andretainer disclosed herein also can be successfully utilized inconnection with other types of medical articles, including other typesof catheters, fluid drainage and delivery tubes and electrical wires.For example, but without limitation, the retainer disclosed herein canalso be configured to receive and secure central venous catheters,peripherally inserted central catheters, hemodialysis catheters,surgical drainage tubes, feeding tubes, chest tubes, nasogastric tubes,scopes, as well as electrical wires or cables connected to external orimplanted electronic devices or sensors. One skilled in the art can alsofind additional applications for the devices and systems disclosedherein. Thus, the illustration and description of the anchoring systemin connection with a Foley catheter is merely exemplary of one possibleapplication of the anchoring system.

The anchoring system described herein is especially adapted to arrestaxial movement of the catheter with a slippery coating, as well as holdthe catheter against the patient. For this purpose, the anchoring system10 utilizes one or more retention mechanisms. The anchoring systemaccomplishes this though without meaningfully impairing (i.e.,substantially occluding) the fluid flow through the catheter to a degreethat would create complications. As described below, such retentionmechanisms involve, among others, the shape of the channel that retainsa section of the catheter, retaining structure either aligned with orpositioned within the channel, a securement barb(s) and/or frictionridge(s) that bites into the catheter body without substantiallyoccluding the catheter drainage lumen, and/or cooperating members thatcome together to clamp onto or pin a portion of the catheter (e.g., awebbing formed between the branches at the Foley catheter Y-site).

The anchoring system also desirably releasably engages the catheter.This allows the catheter to be disconnected from the anchoring system,and from the patient, for any of a variety of known purposes. Forinstance, the healthcare provider can want to remove the catheter fromthe anchoring system to ease disconnection of the catheter from thedrainage tube or to clean the patient. The disengagement of the catheterfrom the anchoring system, however, can be accomplished without removingthe anchoring system from the patient.

Before describing the present anchoring system in detail, a briefdescription of a Foley catheter is provided to assist the reader'sunderstanding of the exemplary embodiment that follows. As bestunderstood from FIG. 6, the catheter 8 includes a proximal tip with aninflatable balloon (not shown) and a distal end 110. The distal end 110includes a Y-site 112 formed by an inflation branch 114 and a drainagebranch 116. The drainage branch 116 and the inflation branch 114 mergetogether at the Y-site 112. The lumens of these branches assume either acoaxial or side-by-side arrangement on the proximal side of the Y-site112 to form a main catheter body 118. On the distal side of the Y-site112, a webbing 120 extends between the two branches 114, 116 at a pointnext to the Y-site 112.

With reference now to FIGS. 1 to 3, the anchoring system 10 includes ananchor pad 12 and a retainer 20. The anchor pad 12 secures the retainer20 to a patient's skin. The anchor pad 12 has a lower adhesive surface16 which adheres to the skin of a patient and a roughened upper surface14 which supports a retainer 20. The retainer 20 is configured to acceptand retain a section of a Foley catheter 8 within the anchoring system10. In the illustrated embodiment, the retainer comprises a base 22 anda cover 24. The cover 24 is detachably secured to the base 22 andmoveable between open and closed positions.

To assist in the description of these components of the anchoring system10, the following coordinate terms are used. A “longitudinal axis” isgenerally parallel to the section of the catheter 8 retained by theanchoring system 10. A “lateral axis” is normal to the longitudinal axisand is generally parallel to the plane of the anchor pad 12. A“transverse axis” extends normal to both the longitudinal and lateralaxes. In addition, as used herein, “the longitudinal direction” refersto a direction substantially parallel to the longitudinal axis; “thelateral direction” refers to a direction substantially parallel to thelateral axis; and “the transverse direction” refers to a directionsubstantially parallel to the transverse axis. Also, the terms“proximal” and “distal”, which are used to describe the presentanchoring system 10, are used consistently with the description of theexemplary application. Thus, proximal and distal are used in referenceto the center of the patient's body. A detailed description of theanchoring system 10, and its associated method of use, now follows.

FIGS. 1 to 3 illustrate an anchor pad 12 which desirably comprises alaminate structure with an upper foam layer (e.g., closed-cellpolyethylene foam), and a lower adhesive layer. The lower adhesive layerconstitutes the lower surface 16 of the anchor pad 12. The lower surface16 desirably is a medical-grade adhesive and can be either diaphoreticor nondiaphoretic, depending upon the particular application. Such foamwith an adhesive layer is available commercially from Avery Dennison ofPainsville, Ohio. Although not illustrated, it will be understood thatthe anchor pad 12 can include suture holes in addition to the adhesivelayer to further secure the anchor pad 12 to the patient's skin.

A surface of the upper foam layer constitutes an upper surface 14 of theanchor pad 12. The upper surface 14 can be roughened by corona-treatingthe foam with a low electric charge. The roughened or porous uppersurface 14 can improve the quality of the adhesive joint (which isdescribed below) between the base 22 and the anchor pad 12. In thealternative, the flexible anchor pad 12 can comprise a medical-gradeadhesive lower layer, an inner foam layer and an upper paper or otherwoven or nonwoven cloth layer.

A removable paper or plastic release liner 18 desirably covers theadhesive lower surface 16 before use. The liner 18 preferably resiststearing and desirably is divided into a plurality of pieces to easeattachment of the pad to a patient's skin. In the illustratedembodiment, the liner 18 is split along a center line 19 of the flexibleanchor pad 12 in order to expose only half of the adhesive lower surface16 at one time.

The liner 18 length, as measured in the lateral direction, extendsbeyond the center line 19 of the anchor pad 12 and is folded over, orback onto the liner 18. This folded over portion defines a pull tab 17to facilitate removal of the liner 18 from the adhesive lower surface16. A medical attendant uses the pull tab 17 by grasping and pulling onit so that the liner 18 is separated from the lower surface 16. The pulltab 17 overcomes any requirement that the medical attendant pick at acorner edge or other segment of the liner 18 in order to separate theliner 18 from the adhesive layer. The pull tab 17 of course can bedesigned in a variety of configurations. For example, the pull tab 17can need not be located along a center line 19 of the anchor pad 12;rather, the pull tab 17 can be located along any line of the anchor pad12 in order to ease the application of the anchor pad 12 onto thepatient's skin at a specific site. For example, an area of a patient'sskin with an abrupt bend, such as at a joint, can require that the pulltab 17 be aligned toward one of the lateral ends of the anchor pad 12rather than along the center line 19.

In the illustrated embodiment, the anchor pad 12 also desirably includesa pair of opposing concave sections 13, 15 that narrows the center ofthe anchor pad 12 proximate to the base 22. As a result, the lateralsides of the anchor pad 12 have more contact area which provides greaterstability and adhesion to a patient's skin.

With reference now to FIGS. 4-10, the retainer 20 includes a rigidstructure principally formed by the base 22 and the cover 24. In theillustrated embodiment, the base 22 and cover 24 are integrally formedto comprise a unitary retainer 20. This can be accomplished in any of avariety of ways well known to those skilled in the art. For instance,the entire retainer 20 can be injection molded in order to reducefabrication costs.

Additionally, as will be apparent from the below description, severalfeatures of the retainer (e.g., a latch keeper and a hinge) desirablyare flexible. Suitable ridged but flexible materials include, forexample, but without limitation, plastics, polymers or composites suchas polypropylene, polyethylene, polycarbonate, polyvinylchloride,acrylonitrile butadiene styrene, nylon, olefin, acrylic, polyester, aswell as moldable silicon, thermoplastic urethane, thermoplasticelastomers, thermoset plastics and the like. The illustrated retainer 20preferably is formed by injection molded using polyethylene orpolypropylene material. However, other materials can be utilized, andthe retainer 20 can comprise a non-unitary base 22 and cover 24.

With reference to FIG. 4, a base 22 in the illustrated embodimentcomprises an elongated body of a generally parallelepiped shape. Thebase 22, however, can be configured in a wide variety of shapes as well,such as circular, square, triangular or the like in order to suit aparticular application. The longitudinal dimension of the base 22 thoughdesirably is sufficiently long to provide stability to the catheter 8along its length. That is, the longitudinal length of the retainedcatheter portion is sufficient to inhibit rocking of the catheter 8relative to the retainer 20 (i.e., to prevent the retainer 20 fromacting as a fulcrum for the catheter). Also, the lateral dimension ofthe base 22 desirably allows the healthcare provider to easily andnaturally grip the base 22, as well as provides space on which to locatea hinge 40 and a portion of the latch mechanism 80.

The base 22 includes first and second sides 26, 28. The first side 26lies generally at one lateral end of the base 22, and the second side 28lies at an opposite lateral end of the base 22.

A groove 30 is formed on the base 22 between the first side 26 and thesecond side 28. In the illustrated embodiment, the groove 30 hasgenerally a curvilinear cross-sectional shape. As best seen in FIG. 6,the lower groove 30 is also varied in width (i.e., in the lateraldirection) along its longitudinal length. That is, in the illustratedembodiment, the side walls of the lower groove 30 diverge from eachother in a generally linear manner from one longitudinal side of theretainer 20 to the other longitudinal side of the retainer.

The base 22 of the retainer 20 is attached to the upper surface 14 ofthe anchor pad 12. The base 22 desirably is secured to the upper surface14 by a solvent bond adhesive, such as cyanoacrylate or other bondingmaterial. One such adhesive is available commercially as Part No. 4693from the Minnesota Mining and Manufacturing Company (3M).

As also seen in FIG. 4, the cover 24 has an elongate shape whichdesirably is coextensive with the planar size and shape of the base 22(i.e., desirably has the same geometric shape and size as the base 22);however, the cover 24 need not be the same size or shape as the base 22.For instance, the cover 24 can be sized to extend beyond any of thelateral, traverse, or longitudinal edge of the base 22 or,alternatively, can be sized so as to not extend to the lateral,traverse, or longitudinal edge of the base 22. The cover can alsoinclude a skirt or flange that extends over and/or about the base 22 orany portion thereof.

The cover 24 though desirably has a sufficient size to cover the lowergroove 30 in the base and to accommodate a portion of the latchmechanism 80 and the hinge 40 which operate between the base 22 and thecover 24, as described below. The cover 24 also desirably is of adimension which provides for easy manipulation. For example, the cover'ssize easily accommodates the grasp of a medical attendant.

The cover 24 includes a first side 32 which lies generally at onelateral end of the cover 24. The first side 32 of the cover thereforegenerally corresponds to the first side 26 of the base 22. The cover 24also has a second side 34. The second side 34 lies generally toward alateral end of the cover 24, opposite of the first end, and correspondsgenerally to the second side 28 of the base 22.

An upper groove 36 is formed on an inner side of the cover 24 betweenthe first and second sides 32, 34 of the cover 24 and correspondsgenerally to the lower groove 30 formed in the base 22. The width of theupper groove 36 is also varied in the lateral direction along itslongitudinal length. That is, in the illustrated embodiment, the sidewalls of the upper groove 36 diverge from each other in a generallylinear manner from one longitudinal end of the cover 24 to the otherlongitudinal end.

The cover 24 is flexibly coupled to the base 22 by way of a flexiblecoupling or hinge 40. The coupling 40 desirably comprises a flexibleband 42 that can take any number of forms to mechanically connect thecover 24 to the base 22 while permitting pivotal movement of the cover24 relative to the base 22 so as to enable engagement or disengagementof these parts, as described below. In the illustrated embodiment, theband 42 is formed of flexible material, desirably of the same materialfrom which the base 22 and cover 24 are comprised. Advantageously, thehinge 40 is integrally molded with the base 22 and the cover 24 to forma unitary member, as noted above. The hinge 40 is located at an outeredge of the base 22 and the cover 24; however, the hinge 40 need not belaterally located at an extreme end of the base 22 or cover 24.

As best understood from FIG. 6, the width of the hinge 40, as measuredin the longitudinal direction, is desirably less than that of either thebase 22 or the cover 24 to allow some leeway or play when engaging ordisengaging the cover 24 to the base 22. That is, this shape allows thehinge 40 to twist to some degree to compensate for some manufacturingtolerances; however, the hinge 40 can have at least as large of alongitudinal dimension as the base 22 and the cover 24.

The hinge 40 is desirably integrally formed along a common correspondingexterior surface of the cover 24 and base 22. In the illustratedembodiment, as best understood from FIG. 5 b, the hinge 40 has generallya U-shape when the cover 24 is closed, and extends from both the base 22and the cover 24 in the lateral direction to the side of the retainer20. A gap 44, corresponding to a transverse height of the hinge 40,exists between the base 22 and cover 24. This gap 44, however, can bereduced or eliminated from the retainer for some applications by using adifferent hinge design.

The hinge 40 enables the cover 24 to move between the open position andthe closed positions. The open position, as illustrated in FIG. 4, ischaracterized by exposing the grooves 30, 36 in the base 22 and thecover 24 in the transverse direction and thereby spacing apart the base22 and the cover 24. When in the open position, the retainer 20 iscapable of receiving a portion (e.g., the Y-site 112) of the Foleycatheter 8. The closed position, as illustrated in FIG. 5 a, ischaracterized by the cover 24 lying in contact or near contact with thebase 22 so as to position the upper groove 36 above the lower groove 30.When in the closed position, the retainer 20 surrounds the receivedportion of the catheter.

The hinge 40 need not provide 180° of movement of the cover 24 relativeto the base 22 to establish the closed position and a fully openposition, as illustrated by FIGS. 5 b and 6. For instance, the hinge 40can permit a smaller degree of movement (e.g., 90°) between the base 22and the cover 24 while still providing enough space to transverselyinsert the catheter into the retainer 20.

The grooves 30, 36 formed in the base 22 and the cover 24 define achannel 60 when the retainer 20 is closed. The channel 60 is capable ofreceiving a portion or length of the catheter 8 and is generallyconfigured to house, grip and secure the affected catheter portion. Thechannel 60 can have a variety of configurations, as discussed above inconnection with the grooves 30, 36, in order to accommodate a particularmedical article. In the illustrated embodiment, the channel 60 generallyhas circular cross-sectional shape at its proximal end 62 and agenerally oblong cross-sectional shape at its distal end 64 (although,in the illustrated embodiment, the distal end 64 is divided by a pair ofcooperating post, which will be described below). The channel smoothlytapers in cross-sectional size from its smaller proximal end 62 to itslarger distal end 64. The channel 60 consequently generally has atruncated V-shape, as best understood by inspecting the shapes of thegrooves 30, 36 in FIG. 6.

In the embodiment illustrated in FIGS. 1-6, the sides of the channel 60are generally straight and diverge from each other. The walls of thechannel 60 (and, thus, the grooves of the cover and base), however, neednot be straight. For example, as seen in FIG. 6 a, the wall of the basegroove 30 can have a convex section that narrows the portion of thechannel that receives the inflation branch 114 of the catheter. Thischannel shape furthers retention of the catheter within the channel 60to inhibit catheter movement through the channel, as discussed below.

Although the channel 60 can take the form of various shapes dependingupon its application (i.e., depending upon a shape of the retainedportion of the medical article for which the retainer is designed to beused), the channel 60 does have a sufficient length in the longitudinaldirection to stabilize the catheter, rather than act as a fulcrum forthe catheter, as mentioned above. That is, the retainer receives asufficient length of the catheter to inhibit movement of the catheter inthe lateral, longitudinal and transverse direction (i.e., to inhibityaw, pitch and axial movement of the catheter), without kinking thecatheter. Also, the wide-mouth shape (i.e., the large oval-shape) of thechannel proximal opening eliminates an edge or surface over which thecatheter could kink.

When the cover 24 is closed, a section of the catheter 8 is capturedwithin the retainer 20. Thus, the retainer 20 at least restricts, if notprevents, lateral and transverse movement of the retained section of thecatheter 8.

Inhibiting movement of the catheter 8 in the longitudinal direction whenthe catheter 8 is secured within the channel 60 is desirablyaccomplished by one or more retention mechanisms that associate with thechannel 60. With reference to FIGS. 4, 5 and 6, one such retentionmechanism involves the shape of the channel 60 itself. The interactionbetween the truncated V-shape of the channel 60 and a correspondingshape of the catheter Y-site 112 inhibits proximal longitudinalmovement.

As best understood from FIG. 6, the proximal end 62 of the channel 60 issized to receive only the main body 118 of the catheter 8. The distalend 64 of the channel 60 is sized to receive both branches 114, 116(i.e., the inflation lumen section and the drainage lumen section) atthe distal side of the Y-site 112. And between its distal and proximalends 64, 62, the channel 60 is configured to receive the catheter Y-site112. In the illustrated embodiment, a second side 68 of the channel 60(formed by the second sides 28, 34 of the base 22 and the cover 24) liesgenerally parallel to a longitudinal axis of the portions of thecatheter drainage lumen received by the channel 60; however, a firstside 66 of the channel 60 (formed by the first sides 26, 32 of the base22 and cover 24) is angled relative to the second side 68. The firstside 66 of the channel 60 desirably varies in a tapering or linearmanner (although it can include a convex section as noted above). Anangle of divergence between the first and second sides 66, 68 of thechannel 60 desirably is between about 10° and about 70°, and morepreferably is between about 30° and about 45°, and generally matches anangle of intersect θ between the two branches 114, 116 of the catheter8, as seen in FIG. 6.

Because the catheter Y-site 112 is large in cross-section than its mainbody 118 and because of the presence of a large valve which is attachedto the catheter inflation branch (see FIG. 13), the Y-site 112 usuallycannot be pulled proximally through the smaller proximal end 62 of theretainer channel 60. The shape of the channel 60 thus inhibitslongitudinal movement of the catheter in the proximal direction.

Variations on the channel's shape of course are also possible, as notedabove. For instance, the second side 68 of the channel 60 can vary fromthe first side 66 in a curvilinear manner and/or can include a gouge,protrusion (FIG. 6 a) or similar geometric abnormality so as tocooperate with or impinge upon a corresponding portion of the receivedcatheter length. Also, there is no requirement that only the first side66 vary relative to an axis A of the received catheter length. Eitherthe first 66 or second 68 side, or both sides, can vary in distancerelative to the axis A of the received catheter length so as to inhibitlongitudinal movement of the retained section of the catheter 8. Thechannel, however, can have a straight or uniform cross-sectional shapewhere the retainer includes at least another mode of the retentionmechanism.

The interaction between the surface 69 of the retainer channel 60 andthe catheter Y-site 112 also creates friction to inhibit longitudinalmovement through the channel 60. The degree of interference between thecatheter 8 and the retainer 20, however, cannot be so great as tosignificantly occlude the catheter 8.

Another retention mechanism to inhibit axial movement of the catheter 8involves one or more friction ridges 70 located on the channel surface69. In the illustrated embodiment, depicted by FIGS. 4 and 9, the ridges70 are integrally formed with the base 22 and the cover 24 and projectinto the channel 60. Because the illustrated embodiment also includessecurement barbs, which will be described below, the friction ridges 70are illustrated in phantom to convey that the ridges 70 can be usedtogether with or in the alternative to the securement barbs.

The ridges 70 are desirably of smooth solid construction; however, theycan be of hollow construction. The ridges in the illustrated embodimenthave generally triangular cross-sectional shapes and angle toward oneend of the channel 60 (e.g., the distal end). The ridges 70, however,can have other cross-sectional shapes which would interfere with axialmovement of the catheter 8 through the channel 60.

In the illustrated embodiment, as best seen in FIG. 6, each of theridges 70 desirably has a front wall or leading edge 72 that forms anangle of less than 90 degrees as measured between the front wall 72 andthe channel surface 69. The ridges 70 slightly protrude into the channel60, desirably at a transverse distance of between 0.1 to 10 mm for thegiven application. As best seen in FIG. 6, the ridges 70 also liegenerally normal to a longitudinal axis through the channel 60.

When so arranged, the friction ridges 70 gently, but securely bite orpress into an outer surface of the catheter Y-site 112. Such contactdoes not occlude or otherwise meaningfully impair fluid flow in thecatheter lumens because of the compliant nature of the catheter bodymaterial and because of the degree to which the ridges bite into thecatheter body. This degree of contact, however, coupled with the angularorientation of the ridges inhibits movement of the catheter 8,especially in a direction opposite of that in which the ridges areangled.

A retaining structure 73, which protrudes into the channel 60, can alsobe used to inhibit axial movement of the catheter. The retainingstructure 73 forms an upstanding member transversely positioned relativeto the anchor pad 12. The retaining structure 73 is arranged to liebetween the branches at the catheter Y-site 112 retained by the retainer20 so as to inhibit axial movement of the catheter 60 in the distaldirection. Thus, in the illustrated embodiment, the combination of thetapering channel shape and the retaining structure 73 inhibits axialmovement of the retained section of the catheter 8 in both the proximaland distal directions.

The retaining structure 73 desirably has a sufficient height to inhibitaxial movement of the catheter 8 in the distal direction. For thispurpose, the retaining structure 73 has a height, in the transversedirection, of at least about 25% of the height of the channel 60 at thelocation at which the structure is positioned. In the presentapplication, the retaining structure desirably extends across channel60.

In the illustrated embodiment, the retaining structure 73 is formed by abase post 74 and a cover post 78. The base post 74 desirably isintegrally formed with the base 22, and is located in the channel 60toward the distal end 64 of the channel 60. The cover post 78 isintegrally formed with the cover 24 also at the distal end 64 of thechannel 60. Although in the illustrated embodiment, the base post 74 andcover post 78 lie within the channel 60, the posts 74, 78 can be locatedoutside the distal end 64 of the channel 60.

In one mode, the base post 74 is sized to extend to a position where itsupper end lies near or contacts the webbing 120 of the catheter 8 thatextends between the Y-site branches 114, 116. In the illustratedembodiment, the upper end of the post 74 lies generally even with theupper surface of the first and second sides 26, 28 of the base 20, asbest seen in FIG. 4. The cover post 78 similarly extends to a pointwhich is generally flush with a plane defined by the inner surfaces ofthe cover first and second sides 32, 34 that lie adjacent to the base22.

As best seen in FIG. 6, the lateral position of the post 74 within thechannel 60 corresponds with the merge point between the inflation lumenbranch 114 and the discharge lumen branch 116 of the Foley catheter 8.The post 74 divides the channel 60 at the channel's distal end 64.

The cover post 78 is configured and arranged on the cover 24 in a mannersimilar to that described above in connection with the post 74 on thebase 22. In the illustrated embodiment, the post 78 thus generallyopposes the base post 74. By this particular design, as understood fromFIG. 6, the combination of the posts 74, 78 and the channel 60 define agenerally Y-shaped recess between the channel's proximal and distal ends62, 64.

In the illustrated embodiment, the transverse height of the cover post78 is less than that of the base post 74. The posts 74, 78, however, canhave equal heights or the cover post 78 can be longer than the base post74. Together though, as best seen in FIG. 5 b, the posts 74, 78desirably span the channel 60 in the transverse direction, except for asmall gap 76 formed at their interface. This gap 76 can be slightly lessthan a thickness of the catheter webbing 120 between the Y-site branches114, 116, for the reasons described below, and corresponds to the gap 44provided by the hinge 40 when the cover 24 is closed.

The posts 74, 78 thus extend between these two branches 114, 116 of thecatheter 8 when the catheter Y-site 112 is positioned within the channel60. Together the posts 74, 78 can act as a stop against longitudinalmovement of the catheter 8 in the distal direction. That is,longitudinal movement in the distal direction causes the catheter Y-site112 to contact the posts 74, 78. The posts 74, 78, being of rigidconstruction, prevent further longitudinal movement.

Although the posts 74, 78 can have a variety of cross-sectional shapes,the posts 74, 78 desirably have a generally triangular cross-sectionalshape in the present application so as to correspond to the spacebetween the two catheter branches 114, 116 at the Y-site 112. Theproximal edge of the posts, however, advantageously is rounded toeliminate sharp contact between the catheter 8 and the retainer 20 atthis location.

The posts 74, 78 can also include interengaging elements to interlockthe posts 74, 78 in the transverse direction and prevent the catheter 8from being pulled through the gap 76 between their ends. In theillustrated embodiment, a pin or projection 81 and a correspondingreceptacle 79 are arranged between the interfacing ends of the posts 74,78. As best seen in FIGS. 4, 5 b and 6, the receptacle 79 is formed atthe transverse end of the base post 74, extending into the post 74 in atransverse direction from an interface surface of the post 74. Theprojection 81 extends from an end of the cover post 78 in a directionparallel to a transverse axis of the post 78. The projection 81 isconfigured to fit within the receptacle 79. When the cover 24 is closed,the pin 81 extends into the receptacle 79 to interlock together theposts 74, 78.

Another possible retention mechanism to inhibit axial movement of thecatheter 8 relative to the retainer 20 involves protuberances that arearranged to cooperate with one another when the cover 24 is closed. Forinstance, in one mode, the cooperating posts 74, 78 can be arranged tocapture a structural portion of the catheter (e.g., the catheter webbing120) between them without substantially occluding an inner lumen of thecatheter 8, as schematically represented in FIG. 6. In another mode, theprojection 81 can be employed without the receptacle 79 to simply pin aportion of the catheter (e.g., its webbing) against a surface of theretainer 20. For instance, the projection 81 can extend from a portionof either the base 22 or the cover 24 and cooperate with a correspondingsurface (be it a post, platform or channel surface) that opposes theprojection 81 when the cover is closed. The projection 81 would protrudeinto the portion of the catheter and pin it against the correspondingsurface.

Alternatively, the projection 81 can be used with the receptacle 79 tocapture a section of the catheter. When the cover 24 is closed, theprojection 81 could force a portion of the catheter body 8 into thereceptacle 79 to capture a structural portion of the catheter 8 betweenthese components without occluding an inner lumen of the catheter. Thisengagement of the retainer 20 with the catheter body 8 would inhibitaxial catheter movement relative to the retainer 20.

One or more securement barbs 80 can also be used to retain the catheterin the longitudinal direction. In the illustrated embodiment, each barb80 has a generally conical shape with a blunt tip. The barb 80, in thepresent application, desirably extends into the channel 60 by an amountranging between about 0.1 mm and about 3 mm.

The retainer desirably includes at least one set of securement barbs 80,indicated collectively by reference numeral 82, which are arrangedwithin the channel 60 to cooperate with one another. The barbs 80advantageously are arranged within the same general lateral plane (i.e.,a plane defined by the lateral and transverse axes), and are spacedapart from one another. In addition, the barbs 80 desirably are spacedon generally opposite surfaces 69 of the channel 60 in a staggeredarrangement. That is, the position of the barbs 80 alternate between thecover surface and the base surface in the lateral direction. Theresulting overlapping pattern of the barbs 80 securely holds thecatheter 8 without imparting torque to the catheter 8 if pulled in alongitudinal direction. In the illustrated embodiment, one barb 80 ispositioned on the cover surface and is generally equally distanced inthe lateral direction from the adjacent side of the channel 60 and theadjacent side of the post 78. A pair of barbs 80 is positioned on thebase surface. These barbs 80 are spaced apart from one another and thepair is symmetrically positioned relative to a transverse axis thatextends through the barb 80 on the cover surface.

The present retainer 20 also includes a second set of securement barbs,indicated collectively by reference numeral 84 (see FIG. 5), which arearranged generally in accordance with the above description; however,fewer number of barbs, as well as fewer sets, can also be used. In theillustrated embodiment, one set of barbs 84 is placed between the posts74, 78 and the first sides 26, 32 of the cover 24 and the base 22, andthe other set of barbs 82 is placed between the posts 74, 78 and thesecond sides 28, 34 of the cover 24 and the base 22. As best seen inFIG. 7, the barbs of the first set 84 are desirably angled toward thedistal end 64 of the channel 60 to inhibit movement of the catheter'sinflation lumen branch 114 in the proximal direction when the catheter 8is pulled proximally, as well as when the catheter 8 discharge branch116 is pulled distally. The barbs of the second set 82, however, aredesirably angled toward the proximal end 62 of the channel 60 to inhibitmovement of the catheter 8 when the catheter's discharge branch 116 ispulled distally.

To firmly hold the affected catheter portion within the channel, thebase 22 and the cover 24 include interengaging structure to couple themtogether in the closed position. In the illustrated embodiment, as bestseen in FIGS. 8-10, a latch mechanism 86 is used to secure the cover 22to the base 24. The latch mechanism 86 comprises at least one moveablekeeper 88 and at least one latch 90. The keeper 88 is arranged on thecover 24 while the latch 90 is arranged on the base 22; however, thesecomponents can be flip-flopped on the base and the cover.

As best seen in FIG. 10, each keeper 88 includes a bar 92 extendingtoward the base 22 from the second side 39 of the cover 24. A tang 94 isformed at a lower end 96 of the bar 92. Desirably, the lower end 96 ofthe bar 92 is relatively blunt and smooth to prevent it from puncturingthe gloves or skin of a healthcare provider or catching on othermaterials. An operator lever 98 extends to the side of the bar 92 andincludes an enlarged platform or ear 100 at its outer end. The platform100 desirably include ridges or knurls, as seen in FIG. 10, on aninclined surface 102. The inclined surface 102 slopes outward in adirection toward the base 22 such that a component of a transverse forceapplied to the surface 102 will cause the bar 92 to deflect inward. Theentire keeper 88 desirably is formed with the cover 24 to form a unitarypiece.

The latch mechanism 86 includes a receptacle 104 that receives the bar92 and the tang 94. The latch receptacle 104 includes an inner notch 106into which the tang 94 snaps when the cover 24 is in the closedposition; however, the tang can be arranged in the receptacle and thenotch be positioned on the bar to accomplish the same effect. The latch90 desirably is formed with the base 22 as a unitary piece.

In the illustrated embodiment, as best seen in FIG. 10, the coverincludes two keepers 88 that are mirror-images of each other. And, asbest seen in FIG. 7, the latch 90 includes two notches 106, each ofwhich is arranged to receive one of the keeper tangs 94 when the cover24 is closed.

An entrance of the receptacle 104 includes chamber edges 107. Thechamfer edges 107 slope inward toward the center of the receptacle 104to cause the keeper bars 92 to bend inward when inserting the keepers 88into the latch receptacle 104.

As best understood from FIGS. 6, 8 and 9, the second side 28 of the base22 also includes a slot 108 to receive a portion of the operator levers98 and the bars 92 of the keepers 88 when the associated tangs 94 areinserted into the receptacle 104. The entrance to the slot 108 alsoincludes a chamfer 109 on its outer edge to facilitate insertion of thekeeper levers 98 into the slot 108.

In operation, the cover 24 can swing toward the closed position. Therelatively thin strip of material forming the coupling allows the hinge40 to bend when finger pressure is exerted on the cover 24 to close it.The lower ends 90 of the keeper bars 92 contact the chamfered edges 107of the latch receptacle 104 when the cover 24 nears its closed position.Continued pressure forces the bars 92 inward (toward each other) topermit the tangs 94 to pass through a narrow section of the receptacle.The slot 108 of the receptacle 104 receives the operator levers 98 asthe tangs 94 are pushed further into the receptacle 104. The tangs 94snap into the notches 106, under the spring force provided by thedeflected bars 92, when the cover 22 sits atop the base 24. Theinteraction between the tangs 94 and the corresponding surfaces of thenotches 106 hold the cover 24 in this position.

As best seen in FIG. 9, the operator levers 98 extend to thelongitudinal sides of the base 24 when the cover 24 is latched. Theplatforms 100 thus remain exposed.

A medical attendant presses downward on the platforms 100 to open thelatch mechanism 80. A downwardly force applied to the angled outersurface 102 exerts an inward force component which deflect thecorresponding bar 92 inward and release the tangs 94 from the notches106. The inherent spring force stored in the bent hinge band 42 assistswith providing a transverse force that moves keepers 88 out of thereceptacle 104. The medical attendant can then open the cover 24 andexpose the inner grooves 30, 36 of the base 22 and the cover 24.

The releasable engagement between the cover 24 and the base 22 allowsthe same retainer 20 to be used for an extended period of time, whilepermitting repeated attachment and reattachment of the catheter to theanchoring system 10. In addition, the hinged connection connecting thecover 24 to the base 22 ensures that the cover 24 will not be lost ormisplaced when the catheter is detached from the anchoring system 10.The medical attendant wastes no time in searching for a cover, nor inorienting the cover prior to latching.

As illustrated in FIGS. 11-13, a medical attendant can secure a Foleycatheter (or other medical article) to a patient using theabove-described anchoring system (or a readily apparent modificationthereof). The medical attendant first opens the retainer 20 to exposethe groove 30 on the base 22. Once opened, a catheter 8 can betransversely aligned over the groove 30. The catheter 8 can then beplaced into the channel 60. If the channel 60 is formed with a post 74(or another protuberance) for use with a Y-site, the first and secondbranches 114, 116 are aligned around the post 74 and the catheter Y-site112 is aligned to securely fit within the remaining groove confines.Once the catheter 8 is so aligned and placed into the groove 30, thecover 24 is closed and latched, in the manner described above. Theshapes of the grooves 30, 36 ensure that the channel supports thecatheter Y-site 112 on at least diametrically opposed sides thereofalong the entire retained length of the catheter Y-site. This not onlyenhances frictional contact between the retainer 20 and the catheter 8,but it also prevents the catheter 8 from kinking or crimping with theretainer 20 and thereby occluding one or more of the catheter lumens.

In the illustrated embodiment, the posts 74, 78 come together with theprojection 81 inserting into the receptacle 79 when the cover is closed.The posts 74, 78 therefore are interlocked in this position to form astop on the distal side of the Y-site 112 that spans entirely across thechannel's transverse length. The securement barbs 80 also bite into thebody of the catheter Y-site 112 to resist movement of the catheterbranches 114, 116 in a direction opposite of the direction in which theyare angled.

If the catheter 8 is pulled in the proximal direction, the tapered shapeof the channel 60 prevents the larger distal end of the Y-site 112 andthe valve on the inflation branch 114 from pulling through the retainer.The second set of securement barbs 84, which bite into the inflationlumen branch 114, also inhibit movement of the catheter in thisdirection. And if the retainer employs posts or projections that clamponto or pin the catheter webbing within the channel, then thisengagement between the retainer and the catheter would further securethe catheter in place.

If the catheter discharge branch 116 is pulled in the distal direction,the interlocked posts 74, 78 inhibit this movement. The first set ofsecurement barbs 82 bite into the discharge branch 116 and also opposemovement of the catheter branch 116 in this direction. A distal pullingforce on the discharge branch 116 also tends to pull the inflation lumenbranch 114 around the posts 74, 78. The second set of securement barbs84 also inhibits this reaction to further anchor the catheter Y-site 112within the retainer 20.

The retainer 20 thus inhibits longitudinal movement of the catheter 8relative to the retainer, even when used with a lubricated catheter. Theholding effect provided by each of the retention mechanisms, however,does not substantially occlude the lumens of the catheter. Theinteraction of the protuberances (i.e., the posts and/or projection)only affects the catheter webbing 120 (or like structure) and does notbear against the catheter body. Likewise, the interaction between theshape of the channel and posts restricts movement of the catheter inboth axial directions, but does not crimp or kink the catheter body whenit is inserted within the channel and about the posts. And although thesecurement barbs bear against the catheter body, their limited bite doesnot significantly occlude or penetrate the corresponding catheter lumen.

The illustration of the retainer as including all of the above-describedforms of the retention mechanisms is merely exemplary. The retainer caninclude only one retention member or possibly several; it need notinclude all. In addition, any combination of the retention members inthe retainer is also possible.

The present anchoring system thus provides a sterile, tight-gripping,needle-and tape-free way to anchor a medical article to a patient. Theretainer thus eliminates use of tape, and if prior protocol requiredsuturing, it also eliminates accidental needle sticks, suture-wound-siteinfections and scarring. In addition, the retainer can be configured tobe used with any of a wide variety of catheters, tubes, wires, and othermedical articles. Patient comfort is also enhanced and application timeis decreased with the use of the present anchoring system.

A retainer in accordance with another embodiment of the invention isillustrated in FIGS. 14-20. Though not illustrated, this retainer alsodesirably used with a flexible anchor pad, as shown in FIGS. 1 and 3, toform the present anchoring system. The principal difference between thisembodiment and the previous embodiment of the retainer lies in theinterengaging structure between the retainer's base and cover.Accordingly, the above description applies equally to the embodiment ofFIGS. 14-20, unless otherwise indicated. In addition, like referencenumerals are used to indicate like features to the two embodiments, withthe letter designation “a” added as a suffix to refer to particularfeatures of the present embodiment.

The principles of the interengaging structure of the present embodimentto provide for releasable engagement between the base 22 a and cover 24a of the retainer 20 a are similar to the principles of the previousembodiment. However, the particular structure and arrangement of theinterengaging structure used to accomplish these principles differs, asdescribed below. Like the previous embodiment, the interengagingstructure of this retainer 20 a uses a latch mechanism 86 a (FIG. 14)comprising a keeper 88 a (FIG. 15) and a moveable latch 90 a (FIG. 15).The keeper 88 a is arranged on the cover 24 a while the latch 90 a isarranged on the base 22 a; however, these components can bealternatively disposed (i.e., flip-flopped) on the base 22 a and thecover 24 a. The latch mechanism 86 a desirably is formed with the base22 a as a unitary piece.

As best seen in FIGS. 15-17, the keeper 88 a depends from the cover 24a. The illustrated keeper 88 a is generally L-shaped, having a first bar200 extending toward the base 22 a from the second side 34 a of thecover 24 a when the cover 24 a is in the closed position. The keeper 88a also has a second bar 202 formed at a lower end of the first bar 200.Desirably, the lower end of the second bar 202 is relatively blunt andsmooth to prevent it from puncturing the gloves or skin of a healthcareprovider or catching on other materials. The keeper 88 a, however, neednot be generally L-shaped, but rather can be generally C-shaped,generally J-shaped, comprise a singular angled bar or the like.

The second bar 202 includes a chamfer along at least a portion of theinner edge 204. The chamfer edge 204 slopes away from the center of thechannel 60 a to assist in releasably engaging the base 22 a and cover 24a, as explained below.

FIGS. 15-17 also show the interengaging structure further comprising alatch 90 a extending from the second side 28 a of the base 22 a. Thelatch has an actuating bar 206, a tang 208, a recess 210, and anoperator lever 212.

The actuating bar 206 extends from the base 22 a and couples the base 22a to the other elements of the latch 90 a. The actuating bar 206 isconfigured so that at least a portion of the bar 206, desirably theupper portion, can bend or give in the lateral direction when a suitablelateral force is applied. This configuration allows the tang 208 to bendinward when the keeper 88 a contacts the tang 208 so that the keeper 88a can advance over the tang and into the recess 210, as detailed below.

The tang 208 extends from the actuating bar 206 in the lateraldirection. The tang 208 defines a ridge having an underside 209 which issuitably sized to accept and retain the keeper 88 a, as described below.The free lateral edge of the tang 208 includes a chamfer 214. Thechamfered edge 214 slopes away from the center of the channel 60 a tofacilitate insertion of the keeper 88 a into the latch 90 a and therebyassist in releasably engaging the base 22 a and the cover 24 a.

The recess 210 is arranged to receive at least a portion of the secondbar 202 of the keeper 88 a when the cover 24 a is moved to the closedposition. The recess 210 provides an open area defined by the actuatingbar 206, the tang 208 and the operator level 212. The recess 210,however, can be arranged on the keeper 88 a and the second bar 202arranged on the latch 90 a to accomplish the same effect.

The operator lever 212 extends from the actuating bar 206 in the lateraldirection and desirably protrudes beyond the second side 28 a of thebase 22 a to allow. a component of a suitable force to deflect theactuating bar 206 in the lateral direction toward the center of thechannel 60 a. The operator lever 212 desirably has a hollow region 216adjacent the recess 210 to accept at least a portion of the keeper 88 awhen the retainer 20 a is moved to the closed position. The illustratedoperator lever 212 is generally U-shaped; however, a variety of otherconfigurations can be used. The free lateral edge 218 of the operatorlever 212 can include a curvature to generally match the curvature of afingertip to assist the medical attendant in pushing on the operatorlever 212 and for other ergonomic purposes. The free end 218 can alsoinclude ridges or knurls (not shown), to assist in maintaining securecontact between the medical attendant's finger tip and the operatorlever 212.

As shown in FIGS. 17-19, in operation, the cover 24 can swing from theopen position toward the closed position. The relatively thin strip ofmaterial forming the hinge 40 a bends when finger pressure is exerted onthe cover 24 a to close it. As the cover 24 a nears its closed position,at least a portion of 88 a the keeper advances into the hollow 216 ofthe operator lever 212, and the chamfer edge 204 of the second bar 202of the keeper 88 a contacts the chamfer edge 214 of the tang 208 of thelatch 90 a. Continued pressure on the cover 24 a is transferred throughthe chamfers 204, 214 to the actuating bar 206, and forces the tang 208and the actuating bar 206 to deflect inward toward the channel 60 a.These forces also cause the first bar 200 of the keeper 88 a, and thusthe second bar 202, to deflect outward, i.e., away from the channel 60a. The recess 210 then receives at least a portion of the second bar 202of the keeper 88 a as the keeper 88 a is pushed further into the hollow216. In this manner, at least portion of the latch 90 a (e.g. tang 208)acts as a gatekeeper or moveable entranceway which selectively allowsfor passage of at least a portion of the keeper 88 a (e.g. second bar202) into the recess 210.

When the second bar 202 extends below the tang 208 and the cover 22 asits atop the base 24 a, the actuating bar 206 and the first bar 200snap back under the spring force provided by their deflection toposition the second bar 202 beneath the tang 208. In this position, thekeeper 88 a and the latch 90 a are interlocked together as the tang 208obstructs passage of the second bar 202 through the entranceway. Theinteraction between the keeper 88 a and the latch 90 a, together withthe obstructed passage, holds the base 22 a and cover 24 a in thisclosed position.

To open the latch mechanism 86 a, the medical attendant presses on theoperator lever 212 in the lateral direction so that the operator lever212 exerts an inward force that deflects the actuating bar 206 in thelateral direction toward the channel 60 a. Inward deflection of theactuating bar 206 inwardly deflects the tang 208, which, in turn, opensthe entranceway so that the second bar 202 can be released from therecess 210. The medical attendant can then open the cover 24 a andexpose the inner grooves 30 a, 36 a of the base 22 a and the cover 24 a.

Referring back to FIGS. 14-16, a transverse force can be used to openthe cover 24 a and assist in moving the keeper 88 a away from the latch90 a. The transverse force can be applied through a variety ofmechanisms. One such mechanism involves the hinge 40 a, where theinherent spring force stored in the bent hinge band 42 a provides thesuitable transverse force. Another such mechanism involves one or moreinterengaging elements arranged between interfacing portions of the base22 a and the cover 24 a. The illustrated embodiment shows three sets ofinterengaging elements, one set arranged near the hinge 40 a and twosets arranged near the latch mechanism 86 a. Each set of interengagingelements include a pin 220 that depends from the cover 24 a and areceiver 222 that recedes into the base 22 a. The pin 220 is configuredto fit within the recess 222 so that when the cover 24 a is closed, thepin 220 extends into the recess 222 to interlock the base 22 a and cover24 a together. The transverse length of the pin 220 is desirably sizedslightly larger than the transverse depth of the receiver 222 (e.g.about 0.05-0.5 mm). By this arrangement, when the cover 24 a is in theclosed position, the first side 32 a of the cover 24 a is offset from(i.e., not in contact with) the first side 26 a of the base 22 a. Thus,the internal spring force stored in the interengaging elements can alsoprovide the suitable transverse force to assist in opening the cover 24a. The interengaging elements also serve to interlock the base 22 a andthe cover 24 a in the longitudinal and lateral directions, similar tothat of the projection 81 a and receptacle 79 a of the previousembodiment.

The releasable engagement between the cover 24 a and the base 22 aallows the same retainer 20 a to be used for an extended period of time,while permitting repeated attachment and reattachment of the catheter tothe anchoring system 10 a. In addition, the hinged connection connectingthe cover 24 a to the base 22 a ensures that the cover 24 a will not belost or misplaced when the catheter is detached from the anchoringsystem. The medical attendant wastes no time in searching for a cover inorienting the cover prior to latching.

FIG. 14 shows the top of the cover 24 a having indicia 224 such as adirectional arrow, to orient the medical attendant. The indicia 224directs the positioning of the retainer 20 a with respect to thecatheter and the patient. The retainer 20 a is desirably arranged sothat the arrow points toward the catheter insertion point.

An anchoring system in accordance with another embodiment of theinvention is illustrated in FIGS. 21-23. The principal differencebetween this embodiment and the previous embodiments is that theretainer is rotatably mounted onto the anchor pad. For this purpose,like reference numerals with a “b” suffix have been used to indicatelike components between the embodiments with the understanding that theabove description of such common components applies equally to theembodiment shown in FIGS. 21-24, unless indicated otherwise. In thisregard, it should be appreciated that the general construction of theretainer is in accordance with the description provided in connectionwith the embodiments illustrated in FIGS. 1-13; however, the latchmechanism of the retainer is in accordance with the description providedin connection with the embodiment illustrated in FIGS. 14-20.

The principles of the present embodiment that provide an anchoringsystem 10 b for securing a catheter are similar to the principles of theprevious embodiments. The present embodiment, however, includes anadditional feature that allows the retainer 20 b to be rotated by atleast some degree, and preferably by 360°, relative to the anchor pad 12b, as described below. For this purpose, in the illustrated embodiment,a mounting post 226 is attached to the anchor pad 12 b and a hole 232 isformed in the base 22 b of the retainer 20 b.

As best seen in FIGS. 21-23, the mounting post 226 is attached to theanchor pad 12 b and the through-hole 232 is formed in the base 22 b ofthe retainer 20 b. The mounting post 226 and through-hole 232 allow theretainer 20 b to pivot relative to the anchor pad 12 b. In theillustrated embodiment, the retainer 20 b can be rotated 360° relativeto a central pivot point fixed to the anchor pad 12 b; however, thedegree of rotation also can be confined.

Relative rotation is advantageous to assist the healthcare provider inattaching and detaching the retainer 20 b to the catheter (not shown).Relative rotation is also advantageous to assist the healthcare providerin adjusting the attached catheter-retainer assemblage so that thecatheter is less likely to become kinked or snagged on an object.Relative rotation is further advantageous to assist in positioning thecatheter in-line with the drainage lumen or other object. In addition,the healthcare provider need not precisely align the retainer relativeto an axis of the catheter before attaching the pad to the patient'sskin. The healthcare provider can coarsely align the anchoring system onthe patient, adhere the pad to the patient's skin and then rotate theretainer to align the channel of the base with the axis of the catheter.The rotatable nature of the retainer thus eases connection anddisconnection of the catheter with the retainer.

As best seen in FIGS. 23 and 24, the illustrated mounting post 226comprises a pedestal 228 and a cap 230 configured for acceptance into athrough-hole 232 formed in the base 22 b of the retainer 20 b. Thepedestal 228 is attached to and extends upwardly from the anchor pad 12b. The pedestal 228 can have a variety of transverse heights, dependingupon the particular application and the particular retainer to which itinteracts. For anchoring Foley catheters and for use with the retainerdescribed in FIGS. 1 and 14, the pedestal 228 desirably has a transverseheight slightly small than that of the base 22 b at the location of thehole 232; that is, the height can be about 1-5 mm, and more particularlyabout 2 mm; however, other heights are also possible. The illustratedpedestal 228 has a generally cylindrical shape, but can be configured ina variety of other shapes, which can match the shape of the hole 232 inthe retainer base 22 b. The diameter of the pedestal 228 is sufficientto perform its structural function of coupling the anchor pad 12 b tothe base 22 b without significantly bending or breaking and desirablyhas a diameter of about 1 to 5 mm and more particularly a diameter ofabout 4 mm; however, larger or smaller diameters are also possible.Thus, the diameter of the pedestal 228 is desirably about twice theheight of the pedestal 228. The pedestal 228 is flared at the bottom toform an annular fillet 246. The fillet 246 provides structural strengthto the pedestal 226 to resist shear and other forces that can otherwisecause the pedestal to break off from the mounting base 242 or otherwisefail.

The cap 230 extends radially outward from the top portion of thepedestal 228. The cap 230 assists in coupling the anchor pad 12 b to thebase 22 b by inhibiting separation of the pedestal 228 from the base 22b, as explained below. The radial diameter of the cap 230 can vary,depending upon the particular application, and desirably is about 1-5mm, and more particularly a diameter of about 2 mm; however, larger orsmaller diameters are also possible. The illustrated cap 230 has a crosssectional shape generally similar to that of the pedestal 228 for easeof manufacture, however, it can be configured in a variety of othercross sectional shapes to generally match the shape of the through-hole232 in the base, which is described below. The cap 230 desirably extendsbeyond the circumference of the pedestal 228 to assist in securelycoupling the anchor pad 12 b to the retainer 20 b, however, the cap 230need not circumscribe the entire pedestal 228 and can comprise only asingle radial member that extends outwardly from the pedestal 228. Thetransverse thickness of the cap 230 is sufficient to perform itsstructural function of coupling the anchor pad 12 a to the retainer 20 bwithout significantly bending or breaking and desirably has a thicknessof about 0.5 to 2 mm and more particularly a thickness of about 1 mm;however, larger or smaller thicknesses are also possible. A chamfer 234can be formed on an upper peripheral edge of the cap 230 to assist inthe assembly of the mounting post 226, as described below. Theillustrated chamfer 234 transversely extends for about one-half thethickness of the cap 230.

The mounting post pedestal 228 desirably have a smooth side surfaces tofacilitate sliding of the retainer 20 b relative to the mounting post226, such that the mounting posts 226 provide a bearing surface for theretainer base 22 b. The top of the cap 230 additionally is smooth andplanar to present a surface that is generally flush with the surface ofthe base 22 b within the channel. It is understood, however, that thecurvilinear configuration of the channel surface of the base 22 b,results in an imperfectly flush surface between the base and the cap230, although the top of the cap 230 could be configured to match thecurvilinear configuration of the surface of the base 22 b and therebypresent a perfectly flush surface. The mounting post 226 has a one-pieceunitary configuration for ease of manufacture and strength; however, themounting post 226 can alternatively comprise a plurality of separatecomponents that attach to form the mounting post 226. Although theillustrated mounting post 226 is generally mushroom shaped with agenerally flat top, the mounting post 226 can also be generallyT-shaped, inversely L-shaped and the like.

The mounting post 226 is desirably formed in unity with a mounting base242 for structural strength; however, the mounting post 226 and themounting base 242 can comprise separate components, as noted below. Themounting base 242 provides a larger footprint, relative to that of themounting post 226, so that the mounting post 226 can be more securelyattached to the anchor pad 12 b and inhibit unintended separation of themounting post 226 from the anchor pad 12 b. For example, if theanchoring system 10 b is adhered to the inner thigh of a bedriddenpatient, movement of the patient can generate forces on the anchoringsystem 10 b. Thus, the larger footprint which the mounting base 242provides, and which the mounting post 226 is preferably in unity with,provides increased securement between the mounting post 226 and anchorpad 12 b and enhances the robustness of the anchoring system.

The mounting base 242 is generally planar to match the upper surface 14b of the anchor pad 12 b. The illustrated plate also has a circularconfiguration, with the mounting post 226 located at the center of theplate so that the retainer 20 b can centrally rotate on the mountingbase 242; however, the base can have other shapes as well.

An upturned lip 242 desirably circumscribes the perimeter of themounting base 242 to form a barrier that inhibits inwardly directedradial forces from shearing or otherwise separating the retainer 20 b ormounting post 226 from the mounting base 242. The illustrated lip 244has a transverse height of about 1-5 mm for this purpose. The lip 244diameter is slightly larger than the lateral width of the retainer 20 b(i.e., larger by about 1 mm); however, the lip 244 can alternatively bearranged to radially abut the retainer 20 b when the retainer 20 brotates on the mounting base 242, or to provide a radial clearancebetween the retainer 20 b and the lip 244. When so configured, the lipdoes not interfere with the interengaging structure (i.e., does notextend transversely above the latching mechanism so as to inhibit themedical attendant's fingers from depressing the latching mechanism, orabut the retainer so as to partially depress the latching mechanism whenthe retainer is rotated). The lip 244 additionally does not extend abovethe bottom of the channel 60 and thus do not present an edge about whichthe catheter could kink. In the illustrated embodiment, the lip 244 isshorter than the mounting post 226. The lip also does not interfere withthe free rotation of the retainer; however, the mounting base 242 andthe retainer 20 b can include cooperating structure which establishesincremental angular positions of the retainer as it rotates over themounting base 242. This can be done by providing a plurality of ratchetteeth about the inner side surface of the lip 244 and a cooperating tangformed on the retainer 20 b. In this manner, the orientation of theretainer 20 b on the mounting base 242 can be set until a sufficientforce is applied to the retainer to overcome the engagement between thetang and the corresponding ratchet teeth.

In the illustrated embodiment, as best understood from FIGS. 23 and 24,the base 22 b of the retainer 20 b has a through-hole 232 sized andconfigured to recover the post and more preferably to generally matchthat of the mounting post 226 so that the retainer 20 b can rotaterelative to the anchor pad 12 b about the mounting post 226. Theillustrated through-hole 232 extends through the base 22 b and has afirst or lower diameter 236 and a second or upper diameter 238. Thelower diameter 236 is slightly larger than that of the pedestal 228 andthe upper diameter 238 is slightly larger than that of the cap 230. Thetolerance between the through-hole 232 and the mounting post 226desirably is about 0.1-0.5 mm and more particularly about 0.1-0.2 mm.Like the mounting post 226, the through-hole 232 has a smooth surface tominimize function when the retainer is rotated. A chamfer 240 cancircumscribe the lower portion of the lower diameter 236 to assist inthe assembly of the rotatable mounting post 226, as described below.

When assembled, the mounting post 226 is arranged within thethrough-hole 232 and secured to the anchor pad 12 b. In particular, thetop of the cap 230 is generally flush with the top of the base 22 b, thecap 230 is housed within the upper diameter 238, the pedestal 228 ishoused within the lower diameter 236, and the bottom of the pedestal 228is secured to the anchor pad 12 b. The mounting base 242 is desirablysecured to the upper surface 14 b of the anchor pad 12 b by a solventbond adhesive, such as cyanoacylate or other bonding material. One suchadhesive is available commercially as Part No. 4693 from the MinnesotaMining and Manufacturing Company (3M). One suitable assembly process,advantageously used when the mounting post 226 and mounting base 242 arein formed in unity, involves bonding the bottom of the mounting base 242to the upper surface 14 b of the anchor pad 12 b and then urging the cap230 of the mounting post 226 through the through-hole 232. The chamfer240 that circumscribes the through-hole 232 and the chamfer 234 thatcircumscribes the cap 230 cooperate to allow the cap 230 to deform andadvance through the through-hole 232. Another suitable assembly process,advantageously used when the mounting post 226 and mounting base 242comprise separate components, involves placing the pedestal 228 throughthe through-hole 232 such that the pedestal 228 extends through thefirst diameter 236 while the cap 230 catches on the second diameter 238,then bonding the bottom of the pedestal 228 to the mounting base 242,and then bonding the mounting base 242 to the anchor pad 12 b. By thisconfiguration, the retainer 20 b can rotate 360° relative to the anchorpad 12 b.

Although this invention has been described in terms of a certainpreferred embodiment and suggested possible modifications thereto, otherembodiments and modifications apparent to those of ordinary skill in theart are also within the scope of this invention. Accordingly, the scopeof the invention is intended to be defined only by the claims whichfollow.

1. An anchoring system for securing a medical article having at least one Y-site to the body of a patient, comprising: an anchor pad having an upper surface and a lower surface, at least a portion of the lower surface having an adhesive surface to attach the anchor pad to the body of the patient, and a retainer mounted on the upper surface of the anchor pad, said retainer being capable of receiving a portion of the medical article, the retainer including a base, a cover, and a post, said base disposed on the upper surface of the anchor pad, said cover being movably connected to the base so as to move between an open position and a closed position, the cover lying above at least part of the base when in the closed position, and the post being coupled to one of said base and said cover and being arranged on said retainer so as to at least partially lie between said cover and said base when the cover is in the closed position and fall within the Y-site at least when the medical article is placed within the retainer and the cover is in the closed position.
 2. An anchoring system as in claim 1, wherein the base and cover cooperate to form a receiving space when the cover lies in the closed position, the receiving space configured to receive at least a portion of the medical article.
 3. The anchoring system as in claim 1, wherein the base defines a receiving space on the retainer, and cover is arranged on the base so as to cover at least a portion of the receiving space when in the closed position.
 4. The anchoring system as in claim 3, wherein a width of the receiving space tapers over its length.
 5. An anchoring system as in claim 3, wherein the receiving space further comprises a protrusion disposed on a portion of the receiving space, the protrusion impinging on a portion of the medical article.
 6. The anchoring system as in claim 3, wherein the cover lies generally to at least one side of the base in the open position to thereby expose the receiving space when the cover is in the open position.
 7. The anchoring system as in claim 3, wherein the post is disposed within the receiving space.
 8. The anchoring system as in claim 3 additionally comprising a latching mechanism operable between the base and the cover to releasably secure the cover to the base.
 9. The anchoring system as in claim 8, wherein the receiving space is disposed at a position between the latching mechanism and a pivotal coupling between the cover and the base.
 10. The anchoring system as in claim 1, wherein the retainer additionally comprises at least one retention mechanism being disposed within the receiving space and including at least first and second members, and the first and second members are arranged to cooperate with one another when the cover is closed so as to be capable of holding a portion of the medical article between the first and second members without substantially occluding an inner lumen of the medical article.
 11. The anchoring system as in claim 1, wherein the retainer additionally comprises means for inhibiting movement of the retained portion of the medical article through the receiving space of the retainer.
 12. The anchoring system as in claim 1, additionally comprising at least one projection and at least one cooperating recess, the projection extending from one of the cover and the base and the recess receding into the other one of the cover and the base, at least a portion of the projection configured to fit within the recess so that when the cover is closed, the projection extends into the recess to inhibit movement of the cover with respect to the base in at least one direction.
 13. An anchoring system as in claim 12, wherein the projection has a length that is greater than a depth of the recess.
 14. The anchoring system as in claim 1, wherein the retainer is rotatably attached to the anchor pad.
 15. An anchoring system for securing an elongated medical article having at least one branching site to the skin of a patient, comprising: an anchor pad having an upper surface and a lower surface, at least a portion of the lower surface formed with an adhesive layer; a retainer rotatably attached to the upper surface of the anchor pad, and comprising a base, post, and a cover pivotally coupled to the base and moveable between an open position and a closed position, the cover and the base cooperating to define at least one channel when the cover lies in the closed position, the channel being configured to receive at least a portion of the elongated medical article, and the post being coupled to one of said base and said cover and being arranged on said retainer so as to at least partially lie between said cover and said base when the cover is in the closed position and fall within the branching site at least when the medical article is placed within the retainer and the cover is in the closed position; and at least one retainer member projecting into the channel and arranged to be capable of engaging a portion of the medical article to inhibit axial movement of the medical article through the channel.
 16. The anchoring system as in claim 15, wherein at least a portion of the channel includes a width, as measured in a lateral direction, which tapers in size.
 17. The anchoring system as in claim 15, further comprising a latching mechanism operable between the base and the cover to secure the cover to the base when the cover is in the closed position.
 18. The anchoring system as in claim 15, wherein the post is disposed within the receiving space.
 19. The anchoring system as in claim 15 additionally comprising a mounting base fixed to the upper surface of the anchor pad, and a rotatable coupling connecting the mounting base to the base of the retainer.
 20. An anchoring system as in claim 19, wherein the rotatable coupling is formed by a mounting post affixed to the mounting base and a receptacle formed in the retainer base, the receptacle receiving the mounting post which defines a rotational axis for the retainer.
 21. An anchoring system for securing an elongated medical article having at least one Y-site to a patient, comprising: an anchor pad having an upper surface and a lower surface; and a retainer mounted on the upper surface of the anchor pad and capable of receiving a portion of the medical article, the retainer including: a base having first and second sides and a post; a cover having a first side and a second side, the first side of the cover being coupled to the first side of the base, and the second side of the cover being movable between a closed position, in which the second side of the cover lies generally above the second side of the base, and an open position, in which the second side of the cover is spaced apart from the second side of the base so as to expose the base, the base and cover defining a receiving space when the cover lies in the closed position, wherein at least a portion of the post lies between the first and second sides of the base and within the Y-site at least when the medical article is placed within the retainer and the cover is in the closed position; and a latching mechanism operable between the base and the cover to releasably secure the second side of the cover to the second side of the base.
 22. The anchoring system as in claim 21, wherein the receiving space includes a proximal end and a distal end, and the width of the receiving space, as measured in a lateral direction, is smaller at the proximal end of the receiving space than at the distal end of the receiving space.
 23. A method of releasably anchoring an elongated medical article including at least one branching site onto a patient, the method comprising: providing an anchoring device which provides an adhesive lower surface, and a retainer comprising a base and a cover; inserting a portion of the medical article including at least the branching site into a groove of the retainer such that at least one branch of the medical article lies to each side of a retaining member disposed upon the retainer; positioning the cover over at least a portion of the retaining member; and securing the anchoring device to the skin of the patient via the adhesive lower surface of the anchoring device.
 24. The anchoring system as in claim 21, wherein the latching mechanism is disposed separately from the post.
 25. An anchoring system for securing an elongated medical article to a patient, comprising: an anchor pad having an upper surface and a lower surface, the lower surface including an adhesive layer on at least a portion of the surface; and a retainer mounted on the upper surface of the anchor pad and capable of receiving a portion of the medical article, the retainer including: a base having first and second sides, and a groove with a generally curvilinear cross-sectional shape; and a cover having a first side and a second side, the first side of the cover being attached to the first side of the base, and the second side of the cover being moveable between a closed position, in which the second side of the cover lies generally above the second side of the base, and an open position, in which the second side of the cover is spaced apart from the second side of the base so as to expose the groove in the base, the cover including a groove having a generally curvilinear cross-sectional shape corresponding in position to the groove in the base to define a channel when the cover lies in the closed position, the defined channel having a curvilinear cross-sectional shape with a cross-sectional area of the channel varying along the length of the channel.
 26. An anchoring system for securing an elongated medical article, comprising: an anchor pad having an upper surface and a lower surface, at least a portion of the lower surface being formed with an adhesive layer; and a retainer permanently affixed to the upper surface of the anchor pad, and comprising, a base having a first generally curvilinear groove to receive at least a portion of the elongated medical article; a cover being pivotally coupled to the base and moveable between an open position in which the groove is exposed, and a closed position in which the groove is covered, the cover including a second generally curvilinear groove that cooperates with the first groove when the cover is in the closed position to define a channel, the channel being configured to support the portion of the medical article received by the retainer on at least diametrically opposed sides thereof along the entire length of the received portion of the medical article; and at least one retention member projecting into the channel and arranged to be capable of engaging a portion of the medical article to inhibit longitudinal movement of the medical article through the channel. 